Trial reportThe New England journal of medicine2003
Comparison of four-drug regimens and pairs of sequential three-drug regimens as initial therapy for HIV-1 infection.
Trial report in The New England journal of medicine, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 65 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Study of Protease Inhibitor and/or Non-Nucleoside Reverse Transcriptase Inhibitor With Dual Nucleosides in Initial Therapy of HIV Infection
A Phase IIIB, Randomized Trial of Open-Label Efavirenz or Atazanavir With Ritonavir in Combination With Double-Blind Comparison of Emtricitabine/Tenofovir or Abacavir/Lamivudine in Antiretroviral-Naive Subjects
Who cites it
65 citing papers in PubMed, 2 syntheses or guidelines pooled it, 231 citations in OpenAlex.
- Genome-wide association study of virologic response with efavirenz-containing or abacavir-containing regimens in AIDS clinical trials group protocols.Pharmacogenetics and genomics · 2015Pooled it
- Nucleoside reverse transcriptase inhibitors in combination therapy for HIV patients: systematic review and meta-analysis.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2010Pooled it
- Higher iron stores and the HFE 187C>G variant delay onset of peripheral neuropathy during combination antiretroviral therapy.PloS one · 2020Trial
- Brain neurotransmitter transporter/receptor genomics and efavirenz central nervous system adverse events.Pharmacogenetics and genomics · 2018Trial
- Racial differences in response to antiretroviral therapy for HIV infection: an AIDS clinical trials group (ACTG) study analysis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2013Trial
- Low baseline CD4+ count is associated with greater bone mineral density loss after antiretroviral therapy initiation.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2013Trial
- Factors associated with remaining on initial randomized efavirenz-containing regimens.AIDS (London, England) · 2013Trial
- CD8+ T-cell activation in HIV-1-infected patients experiencing transient low-level viremia during antiretroviral therapy.Journal of acquired immune deficiency syndromes (1999) · 2013Trial
- Intensification of antiretroviral therapy through addition of enfuvirtide in naive HIV-1-infected patients with severe immunosuppression does not improve immunological response: results of a randomized multicenter trial (ANRS 130 Apollo).Antimicrobial agents and chemotherapy · 2013Trial
- No risk of myocardial infarction associated with initial antiretroviral treatment containing abacavir: short and long-term results from ACTG A5001/ALLRT.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2011Trial
- First-line antiretroviral therapy with a protease inhibitor versus non-nucleoside reverse transcriptase inhibitor and switch at higher versus low viral load in HIV-infected children: an open-label, randomised phase 2/3 trial.The Lancet. Infectious diseases · 2011Trial
- Use of biological knowledge to inform the analysis of gene-gene interactions involved in modulating virologic failure with efavirenz-containing treatment regimens in ART-naïve ACTG clinical trials participants.Pacific Symposium on Biocomputing. Pacific Symposium on Biocomputing · 2011Trial
- Long-term increase in CD4+ T-cell counts during combination antiretroviral therapy for HIV-1 infection.AIDS (London, England) · 2010Trial
- Replication capacity in relation to immunologic and virologic outcomes in HIV-1-infected treatment-naive subjects.Journal of acquired immune deficiency syndromes (1999) · 2009Trial
- Incomplete reconstitution of T cell subsets on combination antiretroviral therapy in the AIDS Clinical Trials Group protocol 384.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2009Trial
- The mitochondrial pharmacogenomics of haplogroup T: MTND2*LHON4917G and antiretroviral therapy-associated peripheral neuropathy.The pharmacogenomics journal · 2008Trial
- Pharmacokinetics of nelfinavir and efavirenz in antiretroviral-naive, human immunodeficiency virus-infected subjects when administered alone or in combination with nucleoside analog reverse transcriptase inhibitors.Antimicrobial agents and chemotherapy · 2005Trial
- Site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy, ACTG 5031: substudy of ACTG 384.HIV clinical trialsTrial
- A randomized, placebo-controlled trial of abacavir intensification in HIV-1-infected adults with virologic suppression on a protease inhibitor-containing regimen.HIV clinical trialsTrial
- Pioneering Role of T.C. Merigan in the Treatment of Various Virus Infections.Molecules (Basel, Switzerland) · 2025Review
5 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
19 authors at 10 institutions in 2 countries.
Funding
Abstract
backgroundIt is unclear whether therapy for human immunodeficiency virus type 1 (HIV-1) should be initiated with a four-drug or two sequential three-drug regimens.
methodsIn this multicenter trial we compared initial therapy involving four-drug regimens containing efavirenz and nelfinavir in combination with either didanosine and stavudine or zidovudine and lamivudine with therapy involving two consecutive three-drug regimens the first of which contained either efavirenz or nelfinavir.
resultsA total of 980 subjects were followed for a median of 2.3 years. There was no significant difference in the occurrence of regimen failures between the group that received the four-drug regimen containing didanosine, stavudine, nelfinavir, and efavirenz and the groups that received the three-drug regimens beginning with didanosine, stavudine, and nelfinavir (hazard ratio for regimen failure, 1.24) or didanosine, stavudine, and efavirenz (hazard ratio, 1.01). There was no significant difference between the group that received the four-drug regimen containing zidovudine, lamivudine, nelfinavir, and efavirenz and the groups that received the three-drug regimens beginning with zidovudine, lamivudine, and nelfinavir (hazard ratio, 1.06) or zidovudine, lamivudine, and efavirenz (hazard ratio, 1.45). A four-drug regimen was associated with a longer time to the first regimen failure than the three-drug regimens containing didanosine, stavudine, and nelfinavir (hazard ratio for a first regimen failure, 0.55); didanosine, stavudine, and efavirenz (hazard ratio, 0.63); or zidovudine, lamivudine, and nelfinavir (hazard ratio, 0.49), but not the three-drug regimen containing zidovudine, lamivudine, and efavirenz (hazard ratio, 1.21).
conclusionsThere was no significant difference in the duration of successful HIV-1 treatment between a single four-drug regimen and two consecutive three-drug regimens. Among these treatment strategies, initiating therapy with the three-drug regimen of zidovudine, lamivudine, and efavirenz is the optimal choice.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.